FDA Medical Device Recalls (openFDA)
Beckman Coulter, Inc.: The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
- Recall number
- Z-0313-2025
- Recalling firm
- Beckman Coulter, Inc.
- Product
- The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
- Status
- Open, Classified
- Initiated
- 2024-09-30
- Posted
- 2024-11-06
- Terminated
- not on file
- Reason
- The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot number. Calibration failure would lead to delay of measurement results reporting and potential injuries.
- Root cause
- Process design
- Action
- Beckman Coulter issue and URGENT MEDICAL DEVICE RECALL notice to its consignees on 09/30/2024 via letter (USPS) and email. The notice explained the issue, the impact to the patient, and requested the use of alternative lot of Access Cortisol reagent. In the event the laboratory cannot generate a passing calibration curve use alternative methodology including alternative Beckman Coulter Access Immunoassay Systems. Beckman Coulter will release an updated Access Cortisol APF on the DxI 9000 Access Immunoassay Analyzer that includes the correct calibration curve acceptance parameter at the S1 calibrator level. A Beckman Coulter representative will contact you when the updated APF is available. The notice is to be shared with laboratory staff and forwarded to all parties to whom the the affected product was distributed.
- Quantity
- 149 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- UDI/DI 15099590231118, all lots
- 510(k) numbers
- ["K223038"]
- PMA numbers
- not on file
- Product code
- CGR
- Firm FEI
- 2122870
- Firm city
- Chaska
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28